BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOFX PLEURISTIK

    MDR report key: 7120669 · Received December 15, 2017

    Report

    Report Number
    3004154314-2017-00027
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 21, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE FOR BREAKING OF THE NANOFX NEEDLES IS UNKNOWN. ACCORDING TO COMPLAINANT, THE SURGEON FELT THAT PATIENT'S BONE WAS VERY HARD WHICH MAY HAVE CAUSED THE BREAKAGE OF THE NEEDLES. THE BROKEN PARTS WERE DISCARDED BY THE FACILITY AND HENCE CANNOT BE RETURNED. THEREFORE, INVESTIGATION OF THE ROOT CAUSE IS NOT POSSIBLE. A REVIEW OF PREVIOUSLY LOGGED COMPLAINTS WAS PERFORMED AND NOTED THAT THIS IS THE FIRST COMPLAINT FROM THE SUSPECT LOT (LOT SIZE - 1080 UNITS). ALSO, THE DHR REVIEW OF THE SUSPECT LOT WAS REVIEWED. NO NONCONFORMITIES OR REJECTS WERE FOUND RELEVANT TO THE ISSUE. ALL TEST RESULTS (MATERIAL ANALYSIS, TENSILE STRENGTH, 100% GAUGE INSPECTION ETC.,) WITHIN THE SPECIFICATIONS AND ALL APPLICABLE STANDARDS. THIS LOT WAS MANUFACTURED IN 2015 AND SINCE HAS BEEN IN THE FIELD WITHOUT ISSUES. FINDINGS FROM PREVIOUS COMPLAINTS INDICATE QUALITY OF BONE, USE OF EXCESSIVE FORCE, WEAR ON THE GUIDE HANDLE, LACK OF THUMB TAB TO RETRACT THE NEEDLE ETC, MAY IMPACT THE FUNCTIONALITY OF THE NANOFRACTURE DEVICE. THE BROKEN FRAGEMENT OF THE FIRST NANOFX NEEDLE WAS RETRIEVED. X-RAY EXAMINATION DID NOT SHOW ANY METAL PIECES OR FRAGEMENTS IN THE BONE. SO, IT IS ASSUMED THAT THE SECOND NANOFX NEEDLE TIP WAS NOT STUCK IN PATIENT'S BONE. (A SEPARATE MEDWATCH REPORT HAS BEEN FILED FOR THE FIRST BROKEN NEEDLE; REFERENCE # 3004154314-2017-00026) THE OUTCOME OF THE CASE WAS NOT AFFECTED BECAUSE OF THE REPORTED ISSUE. THE SURGEON IS SATISIFIED WITH THE OUTCOME. WE WILL CONTINUE TO TRACK AND TREND. THERE WAS NO HARM OR INJURY TO THE USER OR TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 NANOFX NEEDLES BROKE WHILE PERFORMING THE MICROFRACTURE TECHNQIUE. THE EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903081 NANOFX PLEURISTIK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROSURFACE, INC. 75DE1603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other